Fish oil and high blood fats during acute lymphoblastic leukemia treatment
Tests fish oil for high blood fats in acute lymphoblastic leukemia.
Plain-language title generated from the registry record
Registry title: Effect of Fish Oil on Hyperlipidemia and Toxicities in Children and Young Adults With Acute Lymphoblastic Leukemia
Key facts
- Where
- Aalborg, Aarhus, Copenhagen, and Odense, DenmarkSee the 4 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and young adults with acute lymphoblastic leukemia (ALL) treated under the ALLTogether protocol. It tests fish oil against placebo.
- Age
- 1 to 45 years (children 1-17.9 years, young adults 18-45 years)
- Sex
- All sexes can join.
- Disease stage
- ALL put in the very-low risk, intermediate risk low or intermediate risk high group of the ALLTogether protocol.
Main reasons for not taking part
- ALL put in the high risk group after induction treatment in the ALLTogether protocol
- Stem cell transplantation in the ALLTogether protocol
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 45 years old?
Source: NCT04209244, who can take part
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkContact: Steen Rosthøj, MDNot yet recruiting
- Aarhus University HospitalAarhus, DenmarkContact: Birgitte Klug Albertsen, MDNot yet recruiting
- RigshospitaletCopenhagen, DenmarkContact: Renate Dagsdottir Laumann, MScTaking people
- Odense University HospitalOdense, DenmarkContact: Peder Skov Wehner, MDNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Copenhagen University Hospital, Rigshospitalet
- Trial code
- NCT04209244
- Record updated
- 26 December 2019
- Original description
Acute lymphoblastic leukemia (ALL) is the most common malignant disease among children. Treatment results have improved over time due to intensive risk-adapted therapy and the 5-year survival rate is now above 90%. However, the burden of therapy has increased proportionally. Many children develop serious acute and chronic side effects, which impact on the patients expected lifespan and impair their quality of life as a result of therapy. Treatment with PEG-asparaginase and dexamethasone increases the levels of triglycerides and total cholesterol. Consequently, the incidence of hyperlipidemia is high during initial ALL therapy. Studies have suggested that hyperlipidemia is a risk factor for development of osteonecrosis, thrombosis and possibly acute pancreatitis.Read full original descriptionShow less
Effect of Fish Oil Versus Placebo on Hyperlipidemia and Toxicities in Children and Young Adults With Acute Lymphoblastic Leukemia - A Randomized Controlled Trial
Acute lymphoblastic leukemia (ALL) is the most common malignant disease among children. Treatment results have improved over time due to intensive risk-adapted therapy and the 5-year survival rate is now above 90%. However, the burden of therapy has increased proportionally. Many children develop serious acute and chronic side effects, which impact on the patients expected lifespan and impair their quality of life as a result of therapy. Treatment with PEG-asparaginase and dexamethasone increases the levels of triglycerides and total cholesterol. Consequently, the incidence of hyperlipidemia is high during initial ALL therapy. Studies have suggested that hyperlipidemia is a risk factor for development of osteonecrosis, thrombosis and possibly acute pancreatitis.
Long-chained marine omega-3 fatty acids, found in fish oil, decrease levels of triglycerides and total cholesterol in hyperlipidemic patients. Due to the high survival rate, it is of great interest to develop methods to reduce treatment related toxicities.
The investigators hypothesise that daily intake of fish oil will prevent development of hyperlipidemia during ALL treatment phases with dexamethasone and PEG-asparaginase compared to placebo and that fish oil intake may reduce the incidence of severe adverse events related to ALL treatment.
Inclusion: Children (1-17.9 years) and young adults (18-45 years) diagnosed with ALL, stratified to very-low risk (VRL), intermediate risk low (IR-low) and intermediate risk high (IR-high) in the ALLTogether protocol.
Exclusion: Patients diagnosed with ALL, stratified to high risk (HR) after induction treatment or stem cell transplantation in the ALLTogether protocol.